Full Automatic (NIBP) Blood Pressure Monitor

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text. September 16, 2019 Health & Life Co. Itd. J.S. Hsu RA / QA Div. Manager 9F, No. 186 Jian Yi Road Zhonghe District, New Taipei City, 23553 TAIWAN Re: K190507 Trade/Device Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL858CL Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: August 19, 2019 Received: August 22, 2019 Dear J.S. Hsu: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K190507 #### Device Name Full Automatic (NIBP) Blood Pressure Monitor, Model HL858CL #### Indications for Use (Describe) HL858CL automatically measures human's Systolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 inches to 22 inches (approx.23 cm to 56 cm) and for home use. HL858CL detects the appearance of irregular heartbeats during measurement; an indicated symbol will appear with measuring reading. And the Risk Category Indicator will show the information with the readings on the screen for the user tracking their blood pressure level. Besides, the device features a built-in "Bluetooth Data Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth-enabled device. Also, users could simply synchronize the current date and time, and check the battery status of blood pressure montor by means of DailyChek® application software with the paired Bluetooth-enabled device. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> | |----------------------------------------------|-----------------| | Over-The-Counter Use (21 CFR 801 Subpart C) | <span></span> X | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ K190507 # PREMARKET NOTIFICATION # 510(k) SUMMARY (As Required By 21 CFR 807.92) This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. The assigned 510(k) number is: Date: # 1. Submitter: Health & Life Co., Ltd. 9F. No.186, Jian Yi Road, Zhonghe District, New Taipei City, Taiwan, R.O.C TEL: +886-2-8227-1300 FAX: +886-2-8227-1301 Contact person: JS Hsu/ RA & QA Manager. E-mail: js.hsu@hlmt.com.tw Tel: 886-2-8227-1300 ext.1201 Fax: 886-2-8227-1301 #### 2. Name of the Device: Trade Name: Full Automatic (NIBP) Blood Pressure Monitor, Model HL858CL Common Name: Blood Pressure Monitor Classification Name: Non-invasive Blood Pressure Measurement System Classification: Class II, 21 CFR 870.1130 Classification Panel: 74 Cardiovascular Product Code: DXN # 3. Information for the 510(k) Cleared Device (Predicate Device): Full Automatic (NIBP) Blood Pressure Monitor, Model: HL858CC (K160145) {4}------------------------------------------------ #### 4. Device Description: HL858CL automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 inches to 22 inches (approx.23 cm to 56 cm) and for home use. The device will display a symbol O-+-, to indicate the detection of irregular heartbeat rhythm as defined as a rhythm is more than or less than 25% from the average heartbeat intervals during the measurement. Additionally, after measurement, the Risk Category Indicator function will show the information with the readings on the screen for the user tracking their blood pressure level. Besides, when Triple Check mode is turned on by user, the symbol ( ) will display on the LCD. Then press Start/Stop button the device will take three consecutive measurements automatically at 1 minute intervals. After measurements are completed LCD will display the average values of the three measurements. And user can use the Bluetooth Data Transmission function, which provides users an optional choice to log, track and store their measurement data. Also synchronize the current date and time, and check the battery status of blood pressure monitor by means of DailyChek® application software with the paired Bluetooth-enabled device. #### 5. Intended Use HL858CL automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 inches to 22 inches (approx.23 cm to 56 cm) and for home use. HL858CL detects the appearance of irregular heartbeats during measurement; an indicated symbol will appear with measuring reading. And the Risk Category Indicator {5}------------------------------------------------ will show the information with the readings on the screen for the user tracking their blood pressure level. Besides, the device features a built-in "Bluetooth Data Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth-enabled device. Also, users could simply synchronize the current date and time, and check the battery status of blood pressure monitor by means of DailyChek® application software with the paired Bluetooth-enabled device. #### 6. Comparison of device to predicate device: # Product Specification Comparison Table of Subject Device HL858CL, and Predicate Device HL858CC (K160145) | Item | Predicate Device<br>HL858CC (K160145) | Subject Device<br>HL858CL | |------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Method of<br>measurement | Oscillimetric | Same as left | | Measurement<br>Type | During inflation | Same as left | | Range of<br>measurement | Pressure 0- 300mmHg,<br>Rated Range of Determination:<br>40~280mmHg,<br>Pulse 40-199 Beats/minute | Same as left | | Accuracy | Pressure ± 3mmHg<br>Pulse ± 5% | Same as left | | Pressure<br>Changed Rate | 2~5mmHg/sec.<br>(from 90mmHg to 150mmHg) | Same as left | | Display | Liquid Crystal Digital | Same as left | | Power Supply | 6V 1A, 4 × AA/1.5V (LR6) Alkaline<br>batteries, or<br>AC Adapter (Model: SINPRO,<br>HPU15-102 Input: 100-240V AC<br>47-63Hz / Output: 5.99V, DC, 2A) | Same as left | | Storage/<br>Transportation | - 25C to +70 C<br>(-13F to +158 F) | -25 C to 60 C (-13 F ~ +140 F) | | Environment | ≤ 93% R.H. | ≤ 93% R.H. | | Operating<br>Environment | 5℃ ~ 40℃ (41°F~104°F),<br>15% ~ 93% R.H.<br>700~1060hPa | Same as left | | Material | ABS housing and<br>ABS keys | Same as left | | Sets of memory | 2*120, total 240 | Same as left | | Number of<br>Push Button | 7+2 switch control<br>(Start/Stop, Memory (MEM), User<br>1/2, Right (>), Left (<),<br>Date/Time() AM/PM button;<br>Triple Check slider, Rest Assure<br>slider) | 6+1 switch control<br>(Start/Stop, Memory (M), User<br>Select, Bluetooth (), Date/Time<br>(), AM/PM button; Triple<br>Check slider) | | Storage pouch | Yes | No | | Cuff size | Arm circumference approx.<br>23~43cm / 9~17 inch<br>(Universal cuff) | Arm circumference approx.<br>23-43 cm / approx.9~17<br>inches(Universal Cuff)<br>43 ~ 56 cm / approx.17 ~ 22<br> | | Unit Weight | Approx. 393 ± 10g<br>(Excluding cuff and<br>Batteries ) | Approx. 330 ± 5g<br>(Excluding cuff and<br>Batteries ) | | Unit<br>Dimensions | 114×153×70.5mm (L×W×H) | 118×163.8×48mm (L×W×H) | | Risk Category<br>Indicator | Yes<br>(Risk Category Indicator, Four<br>Levels) | Yes<br>(Risk Category Indicator, Five<br>Levels) | | Irregular<br>Heartbeat<br>Detector | Yes<br>(Irregular Heartbeat<br>Detection) | Same as left | | Triple-Check<br>(Multi-Read)<br>Function | Yes | Same as left | | Rest Assure<br>Function | Yes | No | | Bluetooth Data<br>Transmission | 1. Measurement Data<br>Transmission<br>2. Date/Time<br>Synchronization<br>3. Battery Status Check | Same as left | | | | | | | | | | Battery Life | $\geq 200$ times | $\geq 250$ times | | Error symbol | EE / E1 / E2 / E3 / E4 | EE / E1 / E2 / E3 / E4 /<br>Excessive Body Motion<br>Detector | | Accessories | Arm cuff with tube: 23 ~ 43 cm / approx.9 ~ 17 inches<br>(Universal cuff), 4 AA/1.5V<br>(LR6) alkaline batteries,<br>5.99V DC AC Adaptor,<br>instruction manual, pouch, gift<br>box. | Arm cuff with tube: 23 ~ 43 cm / approx.9 ~ 17 inches<br>(Universal cuff), 43 ~ 56 cm<br>/ approx.17 ~ 22 inches<br>(Extra Large cuff),<br>4AA/1.5V (LR6) alkaline<br>batteries, 5.99V DC AC<br>Adaptor, instruction manual,<br>gift box. | {6}------------------------------------------------ {7}------------------------------------------------ # Changes from the predicate devices HL858CC (K160145): - * Modify the Number of Push Button from 7+2 switch control to 6+1 switch control. - * Change the Unit Weight from Approx. 393 ± 10g to Approx. 330 ± 5g. - * Change the Unit Size from Approx. 114 mm (L) x 153 mm (W) x 70.5 mm (H) to Approx. 118 mm (L) x 163.8 mm (W) x 48 mm (H) - * Modify the feature of Risk Category Indicator from Four Levels to Five Levels. - * Remove the Rest Assure Function. - * Modify the Battery Life from ≥ 200 times to ≥ 250 times. - * Change the accessory from with storage pouch to without storage pouch, and add the Extra Large Cuff. - * Modify the error symbol from EE/ E1/ E2/ E3/ E4 to EE/ E1/ E2/ E3/ E4/ Excessive Body Motion Detector. *Add Extra Large cuff to measure. {8}------------------------------------------------ These features have been verified and validated, and do not affect the safety and effectiveness of subject device HL858CL. Please refer to Section 12. Substantial Equivalence Discussion for detail information. In addition, the clinical investigation record please refer to Section 20. Performance Testing- Clinical. #### 7. Discussion of Clinical Tests Performed: HL858CL, which includes the Universal cuff and Extra Large cuff, is compliant to the standard of ISO 81060-2: Second Edition 2013-05-01 Non-invasive sphygmomanometers- Part 2: Clinical validation of automated measurement type. The results of this clinical investigation show that the required limits for mean difference and standard deviation are fulfilled by the subject device HL858CL in the group of 90 subjects with qualified distribution. Thus, all the relevant activities were performed by designate individual(s) and the results demonstrated that the predetermined acceptance criteria were fully met. # 8. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as follows: The subject device was tested to evaluate its safety and effectiveness, including the followings: - EMC Test: IEC 60601-1-2 Edition 4:2014, Medical Electrical Equipment Part a. 1-2: General requirements for safety - collateral standard: Electromagnetic compatibility - Requirements and Tests #### Safety Test: b. -IEC 60601-1:2005. Medical electrical equipment - Part 1: General requirements for basic safety and essential performance -IEC 60601-1-11:2015, Medical electrical equipment-Part 1-11: General Requirement for basic safety and essential performance- Collateral Standard: Requirements for medical electrical systems used in the home healthcare environment - FCC Test: ن FCC 47 CFR Part 15, Subpart B, C {9}------------------------------------------------ # d. Biocompatibility Test: -ISO 10993-1:2009, Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process -ISO 10993-5:2009, Biological evaluation of medical devices-Part 5: Tests for In Vitro cytotoxicity -ISO 10993-10:2010, Third Edition Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization # e. Reliability Test: IEC 80601-2-30 Edition1.1 2013-07 Medical electricalequipment-Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers. - f. Risk Assessment: ISO 14971:2007 Second Edition, Medical devices -Application of risk management to medical devices # g. Software Verification and Validation: -IEC 62304 Ed.1.1:2006+A1:2015, Medical device software - Software life cycle processes, -IEC 60601-1-4 Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems, edition 1.1 # h. Usability Validation: -IEC 62366-1:2015 Medical devices - Application of usability engineering to medical devices -IEC 60601-1-6:2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability # 9. Conclusions: The subject device was tested and fulfilled the requirements of those standards mentioned above, and it has concluded that the subject device is substantially equivalent to the predicate device.